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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: ClinicalTrials.gov
Last refreshed on: 19 February 2015
Main ID:  NCT00753103
Date of registration: 15/09/2008
Prospective Registration: No
Primary sponsor: University Hospital Birmingham NHS Foundation Trust
Public title: Anti-Cytokine Therapy for Vasculitis ACTIVE
Scientific title: Phase II Pilot Cohort Study to Investigate the Safety and Efficacy of Infliximab as Additional Therapy in the Treatment if Anti-Neutrophil Cytoplasm Antibody Associated Vasculitis
Date of first enrolment: January 2003
Target sample size: 37
Recruitment status: Completed
URL:  http://clinicaltrials.gov/show/NCT00753103
Study type:  Interventional
Study design:  Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment  
Phase:  Phase 2
Countries of recruitment
United Kingdom
Contacts
Name:     Lorraine Harper, PhD
Address: 
Telephone:
Email:
Affiliation:  University of Birmingham
Key inclusion & exclusion criteria

Inclusion Criteria:

- Either newly diagnosed or relapsed ANCA associated vasculitis (Wegener's
granulomatosis, microscopic polyangiitis, renal limited vasculitis)

Exclusion Criteria:

- Active infection

- Malignancy

- Pregnancy

- Diagnosis of Churg-Strauss syndrome or anti-glomerular basement membrane antibody
disease



Age minimum: 18 Years
Age maximum: N/A
Gender: Both
Health Condition(s) or Problem(s) studied
Microscopic Polyangiitis
Renal Limited Vasculitis
Wegener's Granulomatosis
Intervention(s)
Biological: Infliximab
Drug: Azathioprine
Drug: Cyclophosphamide
Drug: Methylprednisolone
Drug: Mycophenolate mofetil
Drug: Prednisolone
Procedure: Plasma exchange
Primary Outcome(s)
Time to clinical remission (Birmingham Vasculitis Activity Score 0 or 1) [Time Frame: 0, 6, 10, 14, 26, 39 and 52 weeks]
Secondary Outcome(s)
Adverse events [Time Frame: Weeks 2, 6, 10, 14, 26, 39, 52]
Renal function [Time Frame: Weeks 0, 2, 6, 10, 14, 26, 39, 52]
Vasculitis Damage Index Score [Time Frame: Weeks 0, 14, 26, 39, 52]
Secondary ID(s)
RRK2031
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
Ethics review
Results
Results available:
Date Posted:
Date Completed:
URL:
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